Although Regulations (EU) 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) are in operation in the EU, medical devices legislation in Great Britain… Read More
The European Commission issued an article that announces the expiration of the EU-Switzerland Mutual Recognition Agreement (MRA). The article says: “The Mutual Recognition Agreement (MRA) is one of the key… Read More
Several guidance documents have been published by the Medicines and Healthcare products Regulatory Agency (MHRA) in December 2020 and subsequently, including guidelines on the UK Responsible Person (UKRP) and UK… Read More
Medtech Insight has just recently published an article on the updated guidance from for the post-Brexit era. The Medicines and Healthcare products Regulatory Agency (MHRA) issued a guidance update on… Read More
Did you know that the European Commission has issued Regulation (EU) 2019/1020? This regulation on market surveillance and compliance of products lays out updated requirements on the appointment of EU… Read More
On September 1, 2020, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a new guidance how medical devices will be regulated post-Brexit as of January 1, 2021.… Read More
31 January 2020 was a somewhat significant day as the UK formally left the EU at a strategic point in the implementation of the Medical Devices and IVD Regulations (EU)… Read More
What many may already have expected has now been confirmed. UK Prime Minister Boris Johnson has been forced by the House of Commons to request another delay of Brexit date… Read More
The UK has updated its guidance on the UK Responsible Person. The document is applicable should the UK leave the EU without a deal and includes important details about the… Read More
The UK Notified Body Lloyds Register (LRQA) announced that it will not apply for designation under the medical devices and IVD regulations (MDR and IVDR). The announcement comes at a… Read More
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) publishes guidance about registration fees and requirements for a No-Deal Brexit These include, among others, legislative information, information about CE Marking… Read More
You may already have asked yourself how Brexit may affect your business. This is a very complex question as it strongly depends on the role of your company, your overall… Read More
On June 23, 2016, the United Kingdom (UK) voted for the UK to leave the EU, which is commonly referred to as Brexit. Since then, there has been no clear… Read More
